Assessing Optimal Inhaler Strategies During Acute Exacerbations of COPD (AECOPDs) Using Oscillometry

NCT06495047 | Completed

• 1 other identifier: 2024-10445
• Study Type: observational
• Target: 37
• Locations: 1 country
• Sites: 1

Brief Summary

Chronic Obstructive Pulmonary Disease (COPD) is a persistent lung disease that makes it very difficult to breathe. The airways and the normally 'spongy' lungs themselves are affected. The main treatment is puffers, some which are long-acting (to control persistent symptoms) and some which are short-acting ('rescue' puffers when suddenly feeling short-of-breath). Beyond persisting breathlessness at rest, people with COPD can also experience dangerous "lung-attacks" which can require urgent care visits or even hospitalization for treatment. Amazingly, although COPD is the third leading cause of death worldwide, and COPD lung-attacks are a leading cause of hospitalization in Canada, investigators are still unsure which combination of puffers is most effective at treating lung-attacks. The main objective is to determine which puffer treatment combination (just short-acting, or both short-acting and long-acting) best opens up the lungs to airflow during COPD lung-attacks. A test called oscillometry, which requires only quiet breathing and is so safe that it is regularly used in children, toddlers and even infants, will be used to measure lung function changes. All eligible people with COPD receiving urgent lung-attack treatment who agree to participate will perform three rounds of oscillometry: before any puffers, after only short-acting puffers, and finally after long-acting puffers are also added on. Any potential evidence of side effects will be collected from the chart. Oscillometry tests will be compared to see which puffer strategy best improves flow in the airways. Part of the reason why this has not been well-studied so far is that the standard breathing test, spirometry, requires multiple rounds of forceful breathing which is very difficult, even distressing, for many people with COPD (at rest, let alone during a lung-attack). No studies have ever properly studied which puffer strategy is most effective for lung-attacks. The investigators have experience and expertise with oscillometry, the most appropriate test in this setting, to answer this pressing question. This research addresses an important treatment knowledge gap for this very common lung disease. These results could influence how patients with COPD around the world are treated during lung-attacks so that they can breathe better, sooner.

Conditions

COPD; COPD Exacerbation Acute

Outcome Measures

Primary Outcomes (2)

• Reactance-volume loop area (AXV)

  Parameter collected by intra-breath (within-breath) oscillometry. The area within the reactance-volume curve, during tidal breathing.

  1) At baseline (before bronchodilators); 2) 15-20 minutes after SABD but before LABD; and 3) after SABD and LABD (25-35 minutes following SABD).

• Mean inspiratory minus expiratory respiratory system reactance (mean ∆Xrs)

  Parameter collected by intra-breath (within-breath) oscillometry. The reactance during inspiration, minus the reactance during expiration, during tidal breathing.

  1) At baseline (before bronchodilators); 2) 15-20 minutes after SABD but before LABD; and 3) after SABD and LABD (25-35 minutes following SABD).

Secondary Outcomes (5)

• Visual analog scale (VAS) Dyspnea Score

  1) At baseline (before bronchodilators); 2) 15-20 minutes after SABD but before LABD; and 3) after SABD and LABD (25-35 minutes following SABD).

• Resistance at 5 Hz (R5)

  1) At baseline (before bronchodilators); 2) 15-20 minutes after SABD but before LABD; and 3) after SABD and LABD (25-35 minutes following SABD).

• Reactance at 5 Hz (X5)

  1) At baseline (before bronchodilators); 2) 15-20 minutes after SABD but before LABD; and 3) after SABD and LABD (25-35 minutes following SABD).

• Frequency Dependence of Resistance (R5-20)

  1) At baseline (before bronchodilators); 2) 15-20 minutes after SABD but before LABD; and 3) after SABD and LABD (25-35 minutes following SABD).

• Reactance Area (Ax)

  1) At baseline (before bronchodilators); 2) 15-20 minutes after SABD but before LABD; and 3) after SABD and LABD (25-35 minutes following SABD).

Study Arms (1)

COPD cohort

Males and females aged 40 or greater with any severity of airflow obstruction (GOLD 1-4) who are currently experiencing and receiving treatment for a physician-diagnosed acute exacerbation (AECOPD) with both long-acting and short-acting bronchodilators prescribed by the treating team.

Drug: Long-acting bronchodilator therapy (LABD); Drug: Short-acting bronchodilator therapy (SABD)

Interventions

Long-acting bronchodilator therapy (LABD) DRUG

Long-acting inhaler therapy

COPD cohort

Short-acting bronchodilator therapy (SABD) DRUG

Short-acting inhaler therapy

COPD cohort

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with COPD diagnosed with and receiving treatment for an acute exacerbation (AECOPD) who are being treated with both short-acting and long-acting bronchodilator therapies. Convenience sampling approach.

You may qualify if:

• Males and females, age ≥ 40, who are former/current smokers with a ≥10 pack-year smoking history.
• COPD previously confirmed by spirometry (FEV1/FVC \< 0.7) of any severity (GOLD 1-4).
• Currently experiencing and receiving treatment for a physician-diagnosed AECOPD with both long-acting and short-acting bronchodilators prescribed by their treating team.
• Ability to participate without supplemental oxygen during the oscillometry tests.
• Ability to provide informed consent.

You may not qualify if:

• No COPD diagnosis.
• AECOPD is not the principal cause of urgent care visit, emergency department visit, or hospitalization.
• Treatment strategy in which LABDs were held by the treating medical team (SABD-only approach).
• Participant already performed spirometry on the same day of testing.
• Inability to provide informed consent.

Sponsors & Collaborators

• McGill University Health Centre/Research Institute of the McGill University Health Centre: lead
• MEI/MES I&P Program (McGill University, Thorasys Inc.): collaborator

Study Sites (1)

McGill University Health Centre

Montreal, Quebec, H4A 3J1, Canada

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 30, 2024
• First Posted: July 10, 2024
• Study Start: June 1, 2025
• Primary Completion: June 30, 2025
• Study Completion: July 31, 2025
• Last Updated: April 9, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)